Dr Avindra Nath (NIH intramural study) to give Solve webinar, 21 April

[Bob]

I hear you, @BurnA. I just feel uncomfortable if somehow @viggster is embarrassed or chagrined by some pwME.

I think Brian was simply observing that, until the NIH set up a regular method of communication, it would be nice if all patients had shared the info they had received in personal correspondence, but he understands that people might be reluctant to expose themselves to any resulting controversy. I don't think that there's any point in pretending that we're all angels, and that we never upset each other.

 

[Bob]

I think if they really understood the disdain and contempt - from the friggen medical community!! - and social marginilazation from friends and co-workers and even family....Maybe they would cut us some slack.

They are coming from a place of zero knowledge. And that's the NIH's fault, not the individual researchers' fault. I'm hoping this is a very steep learning curve for everyone at the NIH, especially those involved in the study. They will soon meet patients directly and I'm hoping that will put a face to the suffering (or put the suffering to a face) and that it will suddenly become personal for them and a personal interest. I suspect it might for some of them. Lipkin didn't put us on his bucket list for no reason. Something must have touched him.

 

[Simon]

Just blogged on this
NIH to focus its ‘world-class’ technology and expertise on ME/CFS | #MEAction

and started a thread here

 

[caledonia]

If the NIH wants to stop emails to individual researchers, they need to step up with a better communication system.

 

[viggster]

If the NIH wants to stop emails to individual researchers, they need to step up with a better communication system.

They have sent many emails to ME folks who have sent in questions. NINDS did this partly in the hopes the answers would be shared, to bypass the long and tedious review process for posting public web pages. People in the community who have gotten responses from NINDS that could help answer questions many people have have not been sharing those answers. I agree NIH needs to do better with communications, but they have a lot of rules to follow, especially regarding research with human subjects. The community could help by everyone sharing what they know.

 

[Bob]

If anyone were to want to share any NIH communications anonymously, we could easily arrange that.

 

[Amaya2014]

Much of this back and forth could be alleviated by a dedicated liaison for this study. @viggster the cost of a consultant is not going to equal another researcher. Besides, a researcher is only potentionally adding more theory as opposed to someone doing a specific task that will result in real time benefits.

 

[viggster]

Much of this back and forth could be alleviated by a dedicated liaison for this study. @viggster the cost of a consultant is not going to equal another researcher. Besides, a researcher is only potentionally adding more theory as opposed to someone doing a specific task that will result in real time benefits.

I guess I'm unclear what you're suggesting. Is it that you want NIH to hire a full-time communications person to work on ME? If so, that person would still have to follow all the rules, of which there are many regarding public communications of clinical trials. Also, getting a new full-time position approved can take 6-9 months and has to carry a lot of justification. I recall a lot of difficulty getting a comms person hired for a $200 million cancer-prevention study when I worked at NCI.

If you're suggesting that the community choose one person as an informal liaison with NIH, I'd say that might be a good idea - except good luck trying to find a consensus pick.

 

[Simon]

If the NIH wants to stop emails to individual researchers, they need to step up with a better communication system.

Good point. As Nath said, they are trying to set up a patient panel, and have a website but clearly there's a way to go.

The community could help by everyone sharing what they know

Good point, how?

If anyone were to want to share any NIH communications anonymously, we could easily arrange that.

Good idea, how? Dedicated thread? I know #MEAction have posted Qs, don't know if they have a place for answers.

 

[Bob]

If anyone were to want to share any NIH communications anonymously, we could easily arrange that.

Good idea, how? Dedicated thread? I know #MEAction have posted Qs, don't know if they have a place for answer

If people shared correspondence anonymously, then it could ultimately be posted on a dedicated thread, but we'd need somewhere else for people to post the info anonymously.

The best I can do is to set up a blank Google docs page, which can be edited by anyone without logging in:

https://docs.google.com/document/d/1mSeeUphUJF0eWHpdB4br679KmRAhgi_FR4hXVWgLXPg/edit?usp=sharing

Anyone should feel free to use the page. It's very easy to use. No log in required. Just paste your info into it. Instructions are on the page itself. I'll keep an eye on it, and if anything is posted then I'll copy the info onto the forum. Please feel free to share the web link.

 

[LiveAgain]

An NIH contact person will be useless if they refuse to *really* address patient concerns. My biggest issue was and still is the psychologizers involved. Does anyone know if this petition has been delivered? Any response? I hope Dr. Nath's response isn't THE response.

https://my.meaction.net/petitions/keep-psychiatry-out-of-nih-study-on-me-cfs

In addition to the doctors of concern listed in the petition, I would add there is no longer a reason to include the FMD neurologists. The FMD group is gone, ME/CFS isn't a movement disorder and isn't psychosomatic (their view of FMD, not mine). What is their purpose here? Surely they can be replaced with more suitable neurologists? Perhaps for example, some that have worked on AIDS dementia, neuro Lyme, autoimmune brain disease or MS? You know, diseases that are possibly similar and the researchers working on them believe are real. And wouldn't Dr. Nath want researchers like that involved who might actually add something meaningful?

I'm so torn over this because I get excited when he talks about looking for brain autoantibodies (my worst symptoms are neurologic) but then they still have at least 6 psychobabble people involved - it doesn't make sense!

Below is a classic example of what can happen.. these doctors have found small fiber nerve abnormality in Fibro (many studies have now) and STILL.. AND STILL.. they manage to weave in psych/ mind /body BS. Sooo how about we don't include doctors with these (publicly stated) beliefs to begin with to ensure this doesn't become an issue? But nope, sounds like they aren't budging (even though he said the study is changeable)... so we either have to make peace with it and hope for the best or keep fighting this issue. I'm not really sure which way to go..

https://www.ncbi.nlm.nih.gov/pubmed/27105483

 

[BurnA]

In the video at 26:42 Nath says " the purpose isn't to ___up a biomarker for chronic fatigue sydrome, thats not what our goal is...we want to study the pathophysiology ....and identify the immune abnormalities "

Would someone be able to explain what he means by this and why he might exclude a biomarker from the study goals ? Thanks.

 

[Bob]

In the video at 26:42 Nath says " the purpose isn't to ___up a biomarker for chronic fatigue sydrome, thats not what our goal is...we want to study the pathophysiology ....and identify the immune abnormalities "

Would someone be able to explain what he means by this and why he might exclude a biomarker from the study goals ? Thanks.

I think it means it's a deeper and more comprehensive study that solely looking for a biomarker. They want to understand the disease process and find treatments, not just find a biomarker, and job finished. If they find a biomarker along the way, I'm sure they'll may a big deal of it. A biomarker would obviously be exceptionally useful but it wouldn't necessarily tell us anything about the disease process. (It could do, but not necessarily.)

 

[Bob]

From the webinar transcript.
Dr Nath on recruitment and subgrouping (my emphasis)...

OK, let's go to the next slide here. OK, so who do we want to study? As I said earlier, you know, we want to study patients who have a clear infectious process and then have developed this syndrome. So, you know, we've received a lot criticism because we put down Reeves criteria on there, and I have to admit that, you know, I'm no expert in chronic fatigue syndrome. I didn't know how strongly people felt about poor Dr Reeves. I'd never met him and never knew anything about him.

But the reason we had put it over there is because — not that we want to follow the criteria, and I think that's where all the problems arose — we just wanted to use some kind of a quantification method and his questionnaires had all those kinds of quantification that we could do. So that's really all we wanted to get from there.

But the reality is that, really, the way we designed our study is we're going to bring patients in here and actually demonstrate that they will develop some post-exertional fatigue and without that, they're not even going to make it into our study. So actually it's very, very rigorous criteria, and I think one of the problems arises because you have only clinical criteria. So that's why all this controversy around — and this anxiety around — enrolling patients is an issue. And if you had a good biomarker, it would never be a problem.

We also realize that if you're going to use clinical criteria, not only for this disease but any other disease — and in neurology there are lots of them that way — they never have the perfect criteria and you're going to have some patients who probably don't have the disease, and you're going to have some kind of heterogeneity. But that doesn't actually bother me because as you study those patients you'll find outliers that don't fit into the rest of the group.

And so, depending on your sample size, you can actually add more patients or you can exclude them — the outliers — and re-analyze their data or sometimes the outliers can be actually very interesting. You can study them separately as well.

So there are ways of making adjustments to your study as you go along to try and define a population closer and closer and closer. So let's say I find, you know, there are ten patients out of the forty that are really clustering into a particular type of immune phenotype, then I'll try to understand what those are, and then try to bring in patients who keep matching that phenotype so I can correct right there for them.

 

[duncan]

It still seems to me he is too focused on fatigue - even in PEM, which he inadvertently calls "post-exertional fatigue."

I fear that he is at the starting gate, ready to go, but he may be in the wrong race.

As for the outlier thing, okay with a sample of 150 or 100, but only 40? I'm not convinced. He will be qualifying this on the fly, and although laudable, that is a dicey thing. With that approach comes limitations.

So, it is essential that the NIH recruit only bona fide ME/CFS sufferers.

 

[Amaya2014]

Not sure if anyone posted this earlier and I missed it, but just found this info on MEAction. I appreciate these efforts to increase transparency and foster good communication.

NIH TO FOCUS ITS ‘WORLD-CLASS’ TECHNOLOGY AND EXPERTISE ON ME/CFS

However, Nath said he was eager to get patient input in a more organized manner. Asked about patient representation, he said the ‘extramural folk’ were trying to put together a panel of patient representatives and he would be delighted use the same panel for this study. This could help improve relationships with patients going forward, with a clear way for patients to feed in views, preferably before further decisions are made.

Nath also pointed out that he’d answered many emails from patients; and the NIH has developed its ME/CFS website for patients.

 

[Amaya2014]

I hear you, @BurnA. I just feel uncomfortable if somehow @viggster is embarrassed or chagrined by some pwME. I am against nasty personal emails, but my God!, have these investigators supposedly volunteering for "the CFS cause" been living under a rock?? I think if they really understood the disdain and contempt - from the friggen medical community!! - and social marginilazation from friends and co-workers and even family....Maybe they would cut us some slack.

@duncan I don't know of anyway that anyone could understand what we go through besides being at these appointments. I keep thinking maybe I should wear a body cam cause the behavior of the medical community is beyond believe.

This week I had two appts, one a rheumatologist and the other my new primary care doctor. The rheumy kept referring only to my Fibro. I asked her about the IOM report and to her it was useless due to lack of treatment recommendations (obviously she didn't read in depth).

The new primary told me outright she didn't know anything about CFS. She seemed more interested in what doc had the audacity to make the diagnosis.

I met with both to try and get a work assessment completed so an agency that helps disabled vets find suitable jobs could evaluate my work feasibility. Absolutely no help from the docs! "I'm not trained to make these assessments""I don't do this for CFS...I know nothing about it""I can't help you". All that time and energy for nothing.

I struggled to care for my son that evening. Actually fell asleep on him( a four year old) several times. Dinner was cereal and no bath. I've been dragging trying to avoid a crash and putting this post together had taken an hour.

Unless someone sees this daily or is living it, there is no way they will get it.

I think it would be a huge wake up call if some of these horrific medical exchanges were filmed for all the world to see how we get treated.

 

[Kati]

@duncan I don't know of anyway that anyone could understand what we go through besides being at these appointments. I keep thinking maybe I should wear a body cam cause the behavior of the medical community is beyond believe.

This week I had two appts, one a rheumatologist and the other my new primary care doctor. The rheumy kept referring only to my Fibro. I asked her about the IOM report and to her it was useless due to lack of treatment recommendations (obviously she didn't read in depth).

The new primary told me outright she didn't know anything about CFS. She seemed more interested in what doc had the audacity to make the diagnosis.

I met with both to try and get a work assessment completed so an agency that helps disabled vets find suitable jobs could evaluate my work feasibility. Absolutely no help from the docs! "I'm not trained to make these assessments""I don't do this for CFS...I know nothing about it""I can't help you". All that time and energy for nothing.

I struggled to care for my son that evening. Actually fell asleep on him( a four year old) several times. Dinner was cereal and no bath. I've been dragging trying to avoid a crash and putting this post together had taken an hour.

Unless someone sees this daily or is living it, there is no way they will get it.

I think it would be a huge wake up call if some of these horrific medical exchanges were filmed for all the world to see how we get treated.

Hi @Amaya2014 I am so very sorry thing are difficult for you and that physicians have no clue as of what to do. 'Not my department' is what they all seem to say. It is horrendous.

Your post would be a great testimony for CFSAC which will be next month- you can testify by phone or by email. However I would suggest you testify anonymously to protect yourself and your son.

Best wishes

 

[Valentijn]

... we're going to bring patients in here and actually demonstrate that they will develop some post-exertional fatigue and without that, they're not even going to make it into our study.

But do they understand PEM sufficiently to know who has it and who doesn't? Do they know what the symptoms of PEM are? Do they know when PEM starts? Do they know how to distinguish PEM from other forms of exercise intolerance or DOMS? I'm concerned that they're going to claim "I feel tired after exercise" is sufficient to establish that PEM is present.

And calling it "post-exertional fatigue" seems like a pretty bad start, regarding understanding it. It. Is. Not. Fatigue. It's bodywide pain, it's a headache, it's painfully swollen lymph nodes, it's crashing blood pressure and rising heart rate, it's ataxia ... etc. NOT FATIGUE. If they can't even get that much right, we really are screwed.

As for the outlier thing, okay with a sample of 150 or 100, but only 40?

Agreed. They're being very dismissive regarding concerns of multiple control groups and small sample sizes. How about they have their biostatistician run the relevant computations to figure out what sort of results they'll need to get a statistically significant result? Currently it looks like it's going to be very difficult to find any "significant" abnormalities after correcting for so many comparisons being made.

 

[Kati]

And calling it "post-exertional fatigue" seems like a pretty bad start, regarding understanding it. It. Is. Not. Fatigue. It's bodywide pain, it's a headache, it's painfully swollen lymph nodes, it's crashing blood pressure and rising heart rate, it's ataxia ... etc. NOT FATIGUE.

Bears repeating.